FDA.reportPublic FDA data

EXERCISE BAND ANCHOR STRAPS 10/PK

Primary DI
00610570068951
Brand
EXERCISE BAND ANCHOR STRAPS 10/PK
Company
Bird & Cronin, LLC
Model
08143500
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

Product Codes#

Code, Name table
CodeName
KQZComponent, Traction, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQZComponent, Traction, Non-InvasiveOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00610570068951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570068951006105700689516105700689510610570068951

GMDN Terms#

Term, Definition table
TermDefinition
Traction system head halterA device designed to provide traction to the cervical vertebrae by pulling the head with force from an external traction system. It typically combines several padded straps in a lightweight structure; usually one of the straps is placed under the chin, a second one on the back of the head, and another strap goes around the neck to attach the two other straps together. The device includes one or more rings at the top that permit its attachment to the traction system's cable. It is intended for horizontal and/or vertical traction and is used in orthopaedic and/or physical therapy procedures, including fracture treatment and widening of the intervertebral spaces in the spine.

Sterilization Methods#

Method table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888867484983Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485096Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485102Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485119Arthrex®ARTHREX, INC.KQZ2025-12-10
00810075281514BoneFoamBONE FOAM, INC.KQZ2025-08-15
10888867502717Arthrex®ARTHREX, INC.KQZ2025-08-14
20845854082925ParadigmConmed CorporationKQZ2023-06-13
20845854082932ParadigmConmed CorporationKQZ2023-06-13
2078755101165890403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
20787551011672NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
00816342020718Parcus InstrumentationPARCUS MEDICAL LLCKQZ2022-12-06
00842331141027Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331143373Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331136627Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-10
00610570001712100 FT. 3/16" TRACTION CORDBird & Cronin, LLCKQZ2022-08-20
006105700017501500 FT. 3/16" TRACTION CORDBird & Cronin, LLCKQZ2022-08-20
00610570006588BUCKS BOOT XSBird & Cronin, LLCKQZ2022-08-20
00610570006595BUCKS BOOT SMBird & Cronin, LLCKQZ2022-08-20
00610570006601BUCKS BOOT MDBird & Cronin, LLCKQZ2022-08-20
00610570006618BUCKS BOOT LGBird & Cronin, LLCKQZ2022-08-20
00610570006649BUCKS BOOT UNIV CLSD-COMPLETEBird & Cronin, LLCKQZ2022-08-20
00610570006656DISPOSABLE PAD-UNIVERSAL BOOTBird & Cronin, LLCKQZ2022-08-20
00610570006663SADDLE FOR UNIV BUCKS TRACTIONBird & Cronin, LLCKQZ2022-08-20
00610570011810DISKARD HEAD HALTERBird & Cronin, LLCKQZ2022-08-20
00610570011858DELUXE HEAD HALTER UNIV BLACKBird & Cronin, LLCKQZ2022-08-20
00610570012503SPREADER BAR 12" NOTCHEDBird & Cronin, LLCKQZ2022-08-20
0061057001260220# WATER WEIGHT BAGBird & Cronin, LLCKQZ2022-08-20
07290015711302D.B.S. Dynamic Brace SystemMEDITRAC LTD.KQZ2022-07-25
00810075280784Bone FoamBONE FOAM, INC.KQZ2022-05-22
00810075281194Bone FoamBONE FOAM, INC.KQZ2022-05-22