DANNORITZER Medizintechnik GmbH & Co. KG

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) (HET) (9) Electrosurgical, cutting & coagulation & accessories (GEI) (1)

Premarket Exempt

Clear

DANmed - 04251351100031 Catalog Number : LBA-000-000

Device Description : Ring handle, bipolar Ø5mm

Device Class : 2

Duns Number: 314648911

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

DANmed - 04251351100246 Catalog Number : LBB-000-000

Device Description : Ring handle, bipolar Ø5mm

Device Class : 2

Duns Number: 314648911

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

DANmed - 04251351100468 Catalog Number : LBC-000-000

Device Description : Ring handle, bipolar Ø3mm

Device Class : 2

Duns Number: 314648911

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

DANmed - 04251351100499 Catalog Number : LBD-000-000

Device Description : Standard handle, bipolar Ø3mm

Device Class : 2

Duns Number: 314648911

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

DANmed - 04251351100529 Catalog Number : LBF-501-340

Device Description : Bip. coag. forceps, Ø5mm, l=340mm Rippled bar, d/a Bip. coag. forceps, Ø5mm, l=340mm Rippled bar, d/a Spring handle, w. flat plug

Device Class : 2

Duns Number: 314648911

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

DANmed - 04251351100536 Catalog Number : LBF-501-450

Device Description : Bip. coag. forceps, Ø5mm, l=450mm Rippled bar, d/a Bip. coag. forceps, Ø5mm, l=450mm Rippled bar, d/a Spring handle, w. flat plug

Device Class : 2

Duns Number: 314648911

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

DANmed - 04251351100543 Catalog Number : LBF-502-340

Device Description : Bip. coag. forceps, Ø5mm, l=340mm Fluted tip, 1mm, d/a Bip. coag. forceps, Ø5mm, l=340mm Fluted tip, 1mm, d/a Spring handle, w. flat plug

Device Class : 2

Duns Number: 314648911

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

DANmed - 04251351100550 Catalog Number : LBF-502-450

Device Description : Bip. coag. forceps, Ø5mm, l=450mm Fluted tip, 1mm, d/a Bip. coag. forceps, Ø5mm, l=450mm Fluted tip, 1mm, d/a Spring handle, w. flat plug

Device Class : 2

Duns Number: 314648911

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

DANmed - 04251351100567 Catalog Number : LBF-504-340

Device Description : Bip. coag. forceps, Ø5mm, l=340mm Tong-type, bit 3 mm, d/a Bip. coag. forceps, Ø5mm, l=340mm Tong-type, bit 3 mm, d/a Spring handle, w. flat plug

Device Class : 2

Duns Number: 314648911

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

DANmed - 04251351100574 Catalog Number : LBF-504-450

Device Description : Bip. coag. forceps, Ø5mm, l=450mm Tong-type, bit 3 mm, d/a Bip. coag. forceps, Ø5mm, l=450mm Tong-type, bit 3 mm, d/a Spring handle, w. flat plug

Device Class : 2

Duns Number: 314648911

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

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