WELLBRACE

Primary DI: 07798094548555
Brand: WELLBRACE
Company: PANTYMED S.A.
Model: 1201-4519 U XS
Device description: PEDIATRIC PHILADELPHIA NECKLACE - SIZE XS
Published: 2024-02-14
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: false
Sterile: false
Single use: false

Related Records

Product Codes

Code	Name
IQK	Orthosis, Cervical

Product Code Classifications

Code	Device	Specialty	Class
IQK	Orthosis, Cervical	Physical Medicine	1

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
07798094548555	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
07798094548555	07798094548555	7798094548555

GMDN Terms

Term	Definition
Cervical spine collar, reusable	A prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a reusable device.

Term

Definition

Cervical spine collar, reusable

A prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number: 971365986
Device count: 1
DM exempt: false
Premarket exempt: true
HCT/P: false
Kit: false
Combination product: false
Lot or batch: false
Serial number: false
Manufacturing date on label: false
Expiration date on label: false
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

Other Devices From This Company

Primary DI	Brand	Model	Published
07798094540023	WELLBRACE	1601-AR U U	2024-01-08
07798128673581	WELLBRACE	1215-ANR U L	2024-02-29
07798094540160	WELLBRACE	1205-2400R U S	2024-02-28
07798094540177	WELLBRACE	1205-2400R U M	2024-02-28
07798094540184	WELLBRACE	1205-2400R U L	2024-02-28
07798094540191	WELLBRACE	1205-2400R U XL	2024-02-28
07798094540207	WELLBRACE	1205-2400R U 2XL	2024-02-28
07798094540269	WELLBRACE	1205-2800R U S	2024-02-28
07798094540276	WELLBRACE	1205-2800R U M	2024-02-28
07798094540283	WELLBRACE	1205-2800R U L	2024-02-28
07798094540290	WELLBRACE	1205-2800R U XL	2024-02-28
07798094540306	WELLBRACE	1205-2800R U 2XL	2024-02-28
07798094540313	WELLBRACE	1205-2800T U S	2024-02-28
07798094540320	WELLBRACE	1205-2800T U M	2024-02-28
07798094540337	WELLBRACE	1205-2800T U L	2024-02-28
07798094540344	WELLBRACE	1205-2800T U XL	2024-02-28
07798094540351	WELLBRACE	1205-2800T U 2XL	2024-02-28
07798094540368	WELLBRACE	1205-3200R U S	2024-02-28
07798094540924	WELLBRACE	1205-640 U S	2024-02-28
07798094540931	WELLBRACE	1205-640 U M	2024-02-28

Other Devices Sharing Product Codes

Primary DI	Brand	Company	Product code	Published
16946430425079	Lightning X Products, Inc	XIAMEN COMPOWER MEDICAL TECH. CO., LTD	IQK	2025-12-24
16974500613606	Cervical Collar	GCMEDICA ENTERPRISE LTD.(WUXI)	IQK	2025-12-12
00749756399395	DeRoyal	DEROYAL INDUSTRIES, INC.	IQK	2025-07-23
00749756399401	DeRoyal	DEROYAL INDUSTRIES, INC.	IQK	2025-07-23
10810113578801	Vive	VIVE HEALTH LLC	IQK	2025-07-08
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04823097718179	TM "Rehabilitimed" ORTEZ-2V-1 L-90 Comfort	REABILITIMED TOV	IQK	2025-05-04
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04823097718209	TM "Rehabilitimed" ORTEZ-2V-1 M-90 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097718216	TM "Rehabilitimed" ORTEZ-2V-1 M-75 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719701	TM "Rehabilitimed" ORTEZ-2V-1 M-75 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719718	TM "Rehabilitimed" ORTEZ-2V-1 L-75 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719725	TM "Rehabilitimed" ORTEZ-2V-1 XL-75 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719732	TM "Rehabilitimed" ORTEZ-2V-1 M-90 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719749	TM "Rehabilitimed" ORTEZ-2V-1 L-90 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719756	TM "Rehabilitimed" ORTEZ-2V-1 XL-90 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719763	TM "Rehabilitimed" ORTEZ-2V-1 M-110 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719770	TM "Rehabilitimed" ORTEZ-2V-1 L-110 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719787	TM "Rehabilitimed" ORTEZ-2V-1 XL-110 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719909	TM "Rehabilitimed" ORTEZ-2V M-75 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719916	TM "Rehabilitimed" ORTEZ-2V L-75 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719923	TM "Rehabilitimed" ORTEZ-2V XL-75 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719930	TM "Rehabilitimed" ORTEZ-2V M-90 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719947	TM "Rehabilitimed" ORTEZ-2V L-90 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719954	TM "Rehabilitimed" ORTEZ-2V XL-90 Comfort	REABILITIMED TOV	IQK	2025-05-04
04823097719961	TM "Rehabilitimed" ORTEZ-2V M-110 Comfort	REABILITIMED TOV	IQK	2025-05-04