FDA.report

Ab Binder

Primary DI
00850014574567
Brand
Ab Binder
Company
PEPPER MEDICAL INC.
Model
AB430
Catalog number
AB430
Device description
Ab Binder, Small (4 Panel)
Published
2020-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FSDBINDER, ABDOMINAL

Product Code Classifications

CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850014574567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014574567008500145745678500145745670850014574567

GMDN Terms

TermDefinition
Abdominal binder, single-useA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)647-0172gschuster@peppermedical.com

Regulatory Flags

DUNS number
622637098
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

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10850014574823Pepper Medical Closed SuctionCS24-14CS24-142025-09-11
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10850014574960Pepper Medical Closed SuctionCS24-10CS24-102025-09-11
10850014574984Pepper Medical Closed SuctionCS24-DS-12CS24-102025-09-11
10850014575011Pepper Medical Closed SuctionCS24-DS-14CS24-DS-142025-09-11
10850014575028Pepper Medical Closed SuctionCS24-T-14CS24-T-142025-09-11
10850014575042Pepper Medical Closed SuctionCS24-10-ETTCS24-10-ETT2025-09-11
00850014574604PreVent Endo Holder7907902025-03-26
00850014574208Foley Loc6506502020-04-17
00850014574017Trach Tie3003002020-04-17
00850014574024Trach Tie3013012020-04-17
00850014574055Pedi Tie301P301P2020-04-17
00850014574062Vent Tie4014012020-04-17
00850014574086Vent Tie4024022020-04-17
00850014574093Vent Tie4034032020-04-17

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