FDA.report

WELLBRACE

Primary DI
07798094547831
Brand
WELLBRACE
Company
PANTYMED S.A.
Model
1205-3300 U 2XL
Device description
FLEXBAND GIRDLE 3 ADJUSTABLE BANDS - SIZE 2XL
Published
2024-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KDTContainer, Specimen Mailer And Storage, Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
KDTContainer, Specimen Mailer And Storage, SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07798094547831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07798094547831077980945478317798094547831

GMDN Terms

TermDefinition
Abdominal binder, reusableA 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 reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
971365986
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
07798094540023WELLBRACE1601-AR U U2024-01-08
07798128673581WELLBRACE1215-ANR U L2024-02-29
07798094540160WELLBRACE1205-2400R U S2024-02-28
07798094540177WELLBRACE1205-2400R U M2024-02-28
07798094540184WELLBRACE1205-2400R U L2024-02-28
07798094540191WELLBRACE1205-2400R U XL2024-02-28
07798094540207WELLBRACE1205-2400R U 2XL2024-02-28
07798094540269WELLBRACE1205-2800R U S2024-02-28
07798094540276WELLBRACE1205-2800R U M2024-02-28
07798094540283WELLBRACE1205-2800R U L2024-02-28
07798094540290WELLBRACE1205-2800R U XL2024-02-28
07798094540306WELLBRACE1205-2800R U 2XL2024-02-28
07798094540313WELLBRACE1205-2800T U S2024-02-28
07798094540320WELLBRACE1205-2800T U M2024-02-28
07798094540337WELLBRACE1205-2800T U L2024-02-28
07798094540344WELLBRACE1205-2800T U XL2024-02-28
07798094540351WELLBRACE1205-2800T U 2XL2024-02-28
07798094540368WELLBRACE1205-3200R U S2024-02-28
07798094540924WELLBRACE1205-640 U S2024-02-28
07798094540931WELLBRACE1205-640 U M2024-02-28

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