Identity
- Trade Name
- ENDO-SCRUB® FDA UDI
- Generic Name
- Optical medical device procedural cover FDA UDI
- Device Name
- SHEATH 1912015 5PK 4MM/45DEG XOMED FDA UDI
- Model / Reference
- 1912015 FDA UDI
- Description
- SHEATH 1912015 5PK 4MM/45DEG XOMED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20681490697761 FDA UDI
- 510(k) Number
- K982594 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Optical medical device procedural cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 4.0 Millimeter FDA UDIAngle — 45.0 degree FDA UDI
Category: Optical medical device procedural cover
Endo-Scrub® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Optical medical device procedural cover.
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- EndoSheath Technology — COGENTIX MEDICAL, INC. · Class II
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Cleared under the same submission
K982594 also covers:
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
- ENDO-SCRUB® — MEDTRONIC XOMED, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 4dcfe4a9-b28f-4171-8682-20b47c4b393a 36 fields · synced May 30, 2026