FDA.report

BOLSTER,ANGULAR,TORSO,12.5x7.25 IN

Primary DI
00733657243642
Brand
BOLSTER,ANGULAR,TORSO,12.5x7.25 IN
Company
ALIMED, INC.
Model
9-107
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LWGSURGICAL TABLE CUSHION

Product Code Classifications

CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00733657243642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00733657243642007336572436427336572436420733657243642

GMDN Terms

TermDefinition
Freestanding patient positioner, reusableA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(781)329-2900customerservice@alimed.com

Regulatory Flags

DUNS number
056007248
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00733657301038ATEC KIT 4 STRAPS96114529700181532024-08-02
00733657288667ATEC STRAP 2 X 84IN 2 CLOSURE PELVIC LONG96119629700182042024-08-02
00733657288674ATEC STRAP 2 X 72IN 2 CLOSURE PELVIC SHORT96119729700182052024-08-02
00733657288681ATEC STRAP 2 X 42IN 2 CLOSURE THORACIC96119829700182062024-08-02
00733657230253CUSH DROP AWAY POMMEL 16X168892429700113712022-12-15
00733657230260DROP AWAY POMMEL CUSHION 18X168892529700113722022-12-15
00733657240054CATH LAB IMMOBILIZER93189829700134112022-12-15
00733657245035STRAP UNIVERSAL UNIBODY, 5WX65L9-93129700188652022-12-15
00733657283594STRAP UNIVERSAL 3IN X 72IN 10/PK75361029700099892022-12-15
00733657283600STRAP UNIVERSAL 3IN X 72IN 25/PK62575362529700099912022-12-15
00733657283624STRAP UNIVERSAL 4IN x 72IN 10/PK75391029700099962022-12-15
00733657283631STRAP UNIVERSAL 4IN x 72IN 25/PK75392529700099982022-12-15
00733657283648STRAP UNIVERSAL 4IN x 72IN 50/PK75395029700099992022-12-15
00733657283662STRAP UNIVERSAL 4IN x 72IN 100/PK753910029700099972022-12-15
00733657290684ROLLER FOAM FULL ROLL 36" LONG X 6" WIDE ALIMED 3/CS31716032022-12-01
00656204000201HARNESS PAVLIK TYPE51968/NA/LG2022-12-01
00656204000218HARNESS PAVLIK TYPE51968/NA/MD2022-12-01
00656204000225HARNESS PAVLIK TYPE51968/NA/SM2022-12-01
00656204000232HARNESS PAVLIK TYPE51968/NA/XL2022-12-01
00656204004940AFO CHILD LEFT66132/NA/LL2022-12-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850055249431Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249448Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249455Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249462Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249479Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249486Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249493Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249509Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249516Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249011Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249028Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249035Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249042Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249059Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249103Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249233Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249240Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249257Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249264Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249271Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249288Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249295Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249301Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249349Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249356Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249363Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249370Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249387Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249394Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249400Prime Medical LLCPrime Medical LLCLWG2026-03-05