FDA.reportPublic FDA data

ALLEN

Primary DI
00615521013035
Brand
ALLEN
Company
ALLEN MEDICAL SYSTEMS, INC.
Model
103006
Catalog number
750311
Device description
RADIOLUC SPINE SURG FRAME SKN CARE 1 PC.
Published
2023-05-30
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBEDDING, DISPOSABLE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615521013035PackageGS16In Commercial Distribution
00615521030742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615521013035006155210130356155210130350615521013035
00615521030742006155210307426155210307420615521030742

GMDN Terms#

Term, Definition table
TermDefinition
Surgical linen/cushion setA collection of devices intended to be fitted to equipment used to support a patient during surgery (e.g., operating table) to provide a hygienic barrier and positioning/support capabilities. It typically includes operating table sheets, covers, pillows/cushions, foam pads, and equipment drapes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags#

DUNS number
147805894
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
true
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
00615521004354ArthrexAR-1627-052024-05-23
00615521004385ArthrexAR-1627-102024-05-23
00615521004392ArthrexAR-1627-112024-05-23
00615521004408ArthrexAR-1627-11EU2024-05-23
00615521004415ArthrexAR-1627-11UK2024-05-23
00615521004422ArthrexAR-1627-122024-05-23
00615521004439ArthrexAR-1627-12EU2024-05-23
00615521004460ArthrexAR-1627-152024-05-23
00615521004491ArthrexAR-1627-172024-05-23
00615521004507ArthrexAR-1627-182024-05-23
00615521004514ArthrexAR-1627-202024-05-23
00615521004521ArthrexAR-1650-012024-05-23
00615521004552ArthrexAR-1650-042024-05-23
00615521004569ArthrexAR-1650-052024-05-23
00615521004583ArthrexAR-1650-072024-05-23
00615521004590ArthrexAR-1650-082024-05-23
00615521004606ArthrexAR-1650-092024-05-23
00615521004613ArthrexAR-1650-102024-05-23
00615521004620ArthrexAR-1650-112024-05-23
00615521004668ArthrexAR-1713-012024-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859149975678DRY PADPHU BAO GROUP COMPANY LIMITEDKME2026-03-17
00885914997581DRY PADPHU BAO GROUP COMPANY LIMITEDKME2026-03-17
08859149976040DRY PADPHU BAO GROUP COMPANY LIMITEDKME2026-03-17
00850001780353CEGA Innovations, Inc.Cega Innovations, Inc.KME2026-03-12
00850001780377CEGA Innovations, Inc.Cega Innovations, Inc.KME2026-03-12
00748426261284Medline-MicrotekMicrotek Medical LLCKME2026-01-28
00810180842440Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, UniversalDynarex CorporationKME2026-01-05
00850056748230FORWARD APLS Emergency BlanketINTEGRATED MEDCRAFT LLCKME2025-11-25
M68904106020HI-VIS Emergency BlanketSafeguard US Operating, LLCKME2025-09-15
00304040193150Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
00850056748483FORWARD HEAT - Emergency BlanketINTEGRATED MEDCRAFT LLCKME2025-09-02
06979032640093GOBENHUZHOU JUNDA INDUSTRY CO., LTD.KME2025-08-26
50192253014424CARDINAL HEALTHCardinal Health 200, LLCKME2025-08-19
00850061859785GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859792GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859808GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859815GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859822GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859839GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859846GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859853GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
16975675788564RESCUE ESSENTIALSEMSRUN GROUPKME2025-07-18
06931918194168AllesetGRI Medical & Electronic Technology Co., Ltd.KME2025-06-21
06931918129818HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
00616784134420DynaCare Disposable Underpads, Compressed Packaging, Absorbent Fluff Fill Dynarex CorporationKME2025-06-10
08938504806793Pinnakle Moderate UnderpadPHU BAO GROUP COMPANY LIMITEDKME2025-05-30
20889483602918AirLife™AirLife Finland OyKME2025-04-17
20889483602925AirLife™AirLife Finland OyKME2025-04-17
20889483602932AirLife™AirLife Finland OyKME2025-04-17
20889483602949AirLife™AirLife Finland OyKME2025-04-17