Identity
- Trade Name
- Mobius Elastic Retractor FDA UDI
- Generic Name
- Self-retaining surgical retractor, single-use FDA UDI
- Device Name
- Medium; 8-14 cm Incision Range FDA UDI
- Model / Reference
- 900-515 FDA UDI
- Description
- Medium; 8-14 cm Incision Range FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937003802 FDA UDI
- 510(k) Number
- K014005 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Self-retaining surgical retractor, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Self-retaining surgical retractor, single-use
Mobius Elastic Retractor by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Self-retaining surgical retractor, single-use.
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Endo Mini-Retract — Covidien LP · Class II
- Sklar® — Sklar Corporation · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Endo Retract — Covidien LP · Class I
Cleared under the same submission
K014005 also covers:
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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI d002ef9c-cd23-4cf3-9dae-d20622b39053 34 fields · synced Jun 9, 2026