FDA.reportPublic FDA data

UNBRANDED

Primary DI
10848340003605
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
07-PK803
Device description
Custom Pack
Published
2016-10-04
Public version status
Update
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
JAASystem, x-ray, fluoroscopic, image-intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848340003605PackageGS15In Commercial Distribution
00848340003608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000360510848340003605
00848340003608008483400036088483400036080848340003608

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
130785884
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10848340010719C-FlexA-707022026-03-12
10848340010481Mitaka DrapeMU51512024-04-17
10848340011464Mitaka Spy EliteMU1202024-04-17
10848340015530Rolled Probe Cover29-PCS28212024-04-16
10848340016834Rolled Probe Cover29-PCS3520LF2024-04-16
10848340016858Rolled Probe Cover29-PCS0330LF2024-04-16
10848340015547Rolled Probe Cover29-PCS35202024-04-15
10848340012089Sterile Elastic BandsBRB6-5X22024-04-14
10848340015486C-Arm Pack10-21762024-04-14
10848340010160Celfina Cover Motor Module10053442024-04-10
1084834001030612" II Tube Drape (36X36)52584972024-04-10
10848340010320Miniview 6800 C-Arm Drape52616332024-04-10
10848340010276Wide Footswitch Cover52534302024-04-09
108483400102839600/9800/9900 Super C 12"52543822024-04-09
108483400102909600/9800/9900 C-Arm Consu.52559362024-04-09
10848340010238Universal 1/2 Drape52333452024-04-08
10848340010245Gray Footswitch Cover52382592024-04-08
10848340017008Leap Med28-TPUA1702024-04-03
10848340017275Leap Med28-TPUA1722024-04-03
10848340016988Leap Med28-TPU1662024-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10848340010719C-FlexADVANCE MEDICAL DESIGNS, INC.JAA2026-03-12
10680211003266PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-02-02
08809244060601GenorayGENORAY CO., LTD.JAA2025-12-01
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHJAA2025-07-30
10680211003228PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2025-07-21
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.JAA2025-07-11
08809244060465GenorayGENORAY CO., LTD.JAA2025-05-02
40680211003212PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2025-02-25
40680211003205PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2025-02-24
10680211003198PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2025-01-21
10680211003181PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2025-01-20
00195278685001OECHangwei GE Medical Systems Co., Ltd.JAA2025-01-09
10680211003167PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2024-12-05
40680211003175PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2024-12-05
08053307590196NAUTILUSTECHNIX SPAJAA2024-11-06
08053307591070TRIDENTTECHNIX SPAJAA2024-11-06
08053307591087TRIDENTTECHNIX SPAJAA2024-11-06
00190376525921IntraOp Alignment SystemALPHATEC SPINE, INC.JAA2024-10-01
40680211003144PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2024-08-22
10680211003150PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2024-08-22
00680211003139PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2024-08-07
10680211003129PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2024-04-22
10848340010481Mitaka DrapeADVANCE MEDICAL DESIGNS, INC.JAA2024-04-17
10848340011464Mitaka Spy EliteADVANCE MEDICAL DESIGNS, INC.JAA2024-04-17
10848340012089Sterile Elastic BandsADVANCE MEDICAL DESIGNS, INC.JAA2024-04-14
10848340015486C-Arm PackADVANCE MEDICAL DESIGNS, INC.JAA2024-04-14
10848340010160Celfina Cover Motor ModuleADVANCE MEDICAL DESIGNS, INC.JAA2024-04-10
1084834001030612" II Tube Drape (36X36)ADVANCE MEDICAL DESIGNS, INC.JAA2024-04-10
10848340010320Miniview 6800 C-Arm DrapeADVANCE MEDICAL DESIGNS, INC.JAA2024-04-10
10848340010276Wide Footswitch CoverADVANCE MEDICAL DESIGNS, INC.JAA2024-04-09