Identity
- Trade Name
- Glide & Guide Turn System Kit FDA UDI
- Generic Name
- Patient transfer/turning sheet, single-use FDA UDI
- Device Name
- GGTS01 Glide & Guide Turn System Kit Includes: 1 each - GGS3660 and 1 set - BPW10R; 10 Kit/Case FDA UDI
- Model / Reference
- GGTS01 FDA UDI
- Description
- GGTS01 Glide & Guide Turn System Kit Includes: 1 each - GGS3660 and 1 set - BPW10R; 10 Kit/Case FDA UDI
Identifiers
- Catalog Number
- GGTS01 FDA UDI
- Primary DI / UDI-DI
- 00810006683806 FDA UDI
- FDA Product Code
- FMR FDA UDI
- GMDN Term
- Patient transfer/turning sheet, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6785 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Freestanding patient positioner, reusablePatient transfer/turning sheet, single-use
Glide & Guide Turn System Kit by Primo Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient transfer/turning sheet, single-use.
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- Bosma Enterprises — Bosma Enterprises · Class I
- Tortoise™ Turning & positioning system — Mölnlycke Health Care AB · Class I
- Vive — VIVE HEALTH LLC · Class I
- Banana — GBUK LTD · Class I
- Banana — GBUK LTD · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Primo Inc
Sources (1)
- FDA UDI 52c7eab7-ea65-41c6-bb9b-dd47bef6bd46 34 fields · synced Jun 8, 2026