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Gynecological sheaths

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 8753.006Model 10000201270

by Richard Wolf GmbH

Identity

Trade Name
NA FDA UDI
Generic Name
Endoscope sheath, reusable FDA UDI
Device Name
Gynecological sheaths EUDAMED
OUTER SHEATH FOR HYSTEROSCOPE 15.5FR color code green, WL 214 mm, oval, working channel 7 Fr, compatible with hysteroscopy telescope 8753.411, reusable FDA UDI
Model / Reference
10000201270 EUDAMED
8753.006 EUDAMED
8753006 FDA UDI
Description
OUTER SHEATH FOR HYSTEROSCOPE 15.5FR color code green, WL 214 mm, oval, working channel 7 Fr, compatible with hysteroscopy telescope 8753.411, reusable FDA UDI

Identifiers

Catalog Number
8753.006 FDA UDI
Primary DI / UDI-DI
04055207020364 EUDAMEDFDA UDI
Basic UDI-DI
405520711032019-0018270A8 EUDAMED
Direct Marketing DI
04055207020364 EUDAMED
FDA Product Code
HIH FDA UDI
EMDN Code
U0999 UROGENITAL ENDOSCOPIC DEVICES - OTHER EUDAMED
GMDN Term
Endoscope sheath, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
884.1690 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5.16666666666 Millimeter FDA UDI

Gynecological sheaths by Richard Wolf GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Richard Wolf GmbH
EUDAMED SRN
DE-MF-000007048

Sources (2)

  • EUDAMED 2d6a664a-5e3c-4ca2-a9e8-1010b7833470 61 fields · synced Jun 18, 2026
  • FDA UDI 05969942-1a9d-411c-bbc2-dfb8b2e2c016 37 fields · synced May 29, 2026