FDA.report

SERP CERV COLLAR FIRM DENS MD

Primary DI
00610570029068
Brand
SERP CERV COLLAR FIRM DENS MD
Company
Bird & Cronin, LLC
Model
08149903
Published
2022-08-20
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
true

Related Records

Product Codes

CodeName
IQKOrthosis, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
IQKOrthosis, CervicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00610570029068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570029068006105700290686105700290680610570029068

GMDN Terms

TermDefinition
Cervical spine collar, single-useA 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 single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
045975349
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DIBrandModelCatalogPublished
00610570191390B-Cool Chest & AB Binder Wrap081425212023-05-23
00610570191406B-Cool Chest & AB Binder Wrap081425222023-05-23
00610570191413B-Cool Chest & AB Binder Wrap081425242023-05-23
50610570191418B-Cool Chest & AB Binder Wrap081425232023-05-23
00610570191451B-Cool Super Sling Plus Universal (Complete Set)081482612023-02-20
00610570191581Short Anklizer Low Profile Walker XS081491372023-02-20
00610570191598Short Anklizer Low Profile Walker Small081491382023-02-20
00610570191604Short Anklizer Low Profile Walker Medium081491392023-02-20
00610570191611Short Anklizer Low Profile Walker Large081491402023-02-20
00610570191628Short Anklizer Low Profile Walker X-LG081491412023-02-20
00610570191444B-Cool Super Sling Universal (Sling Only)081482602023-02-16
00610570063277APNEA HEAD & CHIN STRAP081482232022-10-31
00610570088065CONTOURED CERV COLLAR 2" UNIV081400392022-10-31
00610570115655PRODY BULB HOLDER081482202022-10-31
00610570166756UNIVERSAL ARM SLING081400152022-08-01
00610570174607ENVELOPE STYLE ARM SLING XS081400612022-08-02
00610570174614ENVELOPE STYLE ARM SLING SM081400622022-08-02
00610570174621ENVELOPE STYLE ARM SLING MD081400632022-08-02
00610570174638ENVELOPE STYLE ARM SLING LG081400642022-08-02
00610570174645ENVELOPE STYLE ARM SLING XL081400652022-08-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16946430425079Lightning X Products, IncXIAMEN COMPOWER MEDICAL TECH. CO., LTDIQK2025-12-24
16974500613606 Cervical CollarGCMEDICA ENTERPRISE LTD.(WUXI)IQK2025-12-12
00749756399395DeRoyalDEROYAL INDUSTRIES, INC.IQK2025-07-23
00749756399401DeRoyalDEROYAL INDUSTRIES, INC.IQK2025-07-23
10810113578801ViveVIVE HEALTH LLCIQK2025-07-08
04823097718131TM "Rehabilitimed" ORTEZ-2V-1 XL-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718148TM "Rehabilitimed" ORTEZ-2V-1 XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097718155TM "Rehabilitimed" ORTEZ-2V-1 XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097718162TM "Rehabilitimed" ORTEZ-2V-1 L-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718179TM "Rehabilitimed" ORTEZ-2V-1 L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097718186TM "Rehabilitimed" ORTEZ-2V-1 L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097718193TM "Rehabilitimed" ORTEZ-2V-1 M-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718209TM "Rehabilitimed" ORTEZ-2V-1 M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097718216TM "Rehabilitimed" ORTEZ-2V-1 M-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719701TM "Rehabilitimed" ORTEZ-2V-1 M-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719718TM "Rehabilitimed" ORTEZ-2V-1 L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719725TM "Rehabilitimed" ORTEZ-2V-1 XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719732TM "Rehabilitimed" ORTEZ-2V-1 M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719749TM "Rehabilitimed" ORTEZ-2V-1 L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719756TM "Rehabilitimed" ORTEZ-2V-1 XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719763TM "Rehabilitimed" ORTEZ-2V-1 M-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719770TM "Rehabilitimed" ORTEZ-2V-1 L-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719787TM "Rehabilitimed" ORTEZ-2V-1 XL-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719909TM "Rehabilitimed" ORTEZ-2V M-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719916TM "Rehabilitimed" ORTEZ-2V L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719923TM "Rehabilitimed" ORTEZ-2V XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719930TM "Rehabilitimed" ORTEZ-2V M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719947TM "Rehabilitimed" ORTEZ-2V L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719954TM "Rehabilitimed" ORTEZ-2V XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719961TM "Rehabilitimed" ORTEZ-2V M-110 ComfortREABILITIMED TOVIQK2025-05-04