FDA.reportPublic FDA data

UNBRANDED

Primary DI
10848340007375
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
25-FF324
Device description
Prove Cover
Published
2016-09-14
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
ITXTransducer, ultrasonic, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848340007375PackageGS125In Commercial Distribution
00848340007378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000737510848340007375
00848340007378008483400073788483400073780848340007378

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
06974405095104CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
06974405095159CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
06974405095166CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
00841517112561Sonosite PXFUJIFILM SONOSITE, INC.ITX2026-03-12
16975424198729Proficient SurgicalEXACT MEDICAL MANUFACTURING, INC.ITX2026-03-11
04987670102721PHASED ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102745LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102752LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102769PHASED ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102783LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102806CW DOPPLER PENCIL TRANSDUCERCANON INC.ITX2026-03-01
04987670102820CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102837ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102844LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102851ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102868ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102875CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102882CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670106507DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
04987670106514DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
04987670106521DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
10885632426711HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426728HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426735HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426742HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426759HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426766HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426773HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426780HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426797HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11