Glide & Guide Turn System Kit

FDA UDI

Class I (US FDA UDI)

by Primo Inc

Identity

Trade Name: Glide & Guide Turn System Kit FDA UDI
Generic Name: Patient transfer/turning sheet, single-use FDA UDI
Device Name: GGTS0B1 Glide & Guide Turn System Kit Includes: 1 each - GGS5660 and 1 set - BPW10R; 10 Kit/Case FDA UDI
Model / Reference: GGTS01B FDA UDI
Description: GGTS0B1 Glide & Guide Turn System Kit Includes: 1 each - GGS5660 and 1 set - BPW10R; 10 Kit/Case FDA UDI

Identifiers

Catalog Number: GGTS01B FDA UDI
Primary DI / UDI-DI: 00810006683813 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Freestanding patient positioner, reusable Patient transfer/turning sheet, single-use

The Glide & Guide Turn System Kit is a versatile and essential tool for healthcare professionals, providing a safe and effective way to assist in the physical movement and transfer of patients. This single-use device is designed to be used as a freestanding patient positioner or preformed patient-contact device, depending on the specific needs of the procedure.

Similar devices

Also classified as Patient transfer/turning sheet, single-use.

Sage TAP LC — SAGE PRODUCTS LLC · Class I
TurnAssist® — Walgreen Health Solutions, LLC · Class I
Mobi-tools translide — MEDI CARE SYSTEM SLU · Class I
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 2efd40bd-4aa6-415d-a608-c648845cb9cf 34 fields · synced Jul 24, 2026