FDA.report

26 ChipSleeve

Primary DI
00745129303846
Brand
26 ChipSleeve
Company
SIGVARIS INC
Model
26TH
Catalog number
2633-THT-L
Device description
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
Published
2024-01-25
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
true

Related Records

Contact Domains

Product Codes

CodeName
KMOBinder, Elastic

Product Code Classifications

CodeDeviceSpecialtyClass
KMOBinder, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00745129303846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129303846007451293038467451293038460745129303846

GMDN Terms

TermDefinition
General-purpose medical foam padding, single-useA roll, sheet or preformed shape of synthetic latex foam material [e.g., styrene-butadiene rubber (SBR)] intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)322-7744sigvariscares@sigvaris.com

Regulatory Flags

DUNS number
189738719
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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00745129333737Chipsleeve Arm No Hand SM Long LT SIGVARIS INCKMO2026-01-09
00745129333744Chipsleeve Arm No Hand SM Long RT SIGVARIS INCKMO2026-01-09
00745129333751Chipsleeve Arm No Hand SM Reg LT SIGVARIS INCKMO2026-01-09
00745129333768Chipsleeve Arm No Hand SM Reg RT SIGVARIS INCKMO2026-01-09
00745129333775Chipsleeve Arm No Hand SM Short LT SIGVARIS INCKMO2026-01-09
00745129333782Chipsleeve Arm No Hand SM Short RT SIGVARIS INCKMO2026-01-09
00745129333799Chipsleeve Arm No Hand MD Long LT SIGVARIS INCKMO2026-01-09
00745129333805Chipsleeve Arm No Hand MD Long RT SIGVARIS INCKMO2026-01-09
00745129333812Chipsleeve Arm No Hand MD Reg LT SIGVARIS INCKMO2026-01-09
00745129333829Chipsleeve Arm No Hand MD Reg RT SIGVARIS INCKMO2026-01-09
00745129333836Chipsleeve Arm No Hand MD Short LT SIGVARIS INCKMO2026-01-09
00745129333843Chipsleeve Arm No Hand MD Short RT SIGVARIS INCKMO2026-01-09
00745129333850Chipsleeve Arm No Hand LG Long LT SIGVARIS INCKMO2026-01-09
00745129333867Chipsleeve Arm No Hand LG Long RT SIGVARIS INCKMO2026-01-09
00745129333874Chipsleeve Arm No Hand LG Reg LT SIGVARIS INCKMO2026-01-09
00745129333881Chipsleeve Arm No Hand LG Reg RT SIGVARIS INCKMO2026-01-09
00745129333898Chipsleeve Arm No Hand LG Short LT SIGVARIS INCKMO2026-01-09
00745129333904Chipsleeve Arm No Hand LG Short RT SIGVARIS INCKMO2026-01-09
00745129333911Chipsleeve Arm No Hand XL Long LT SIGVARIS INCKMO2026-01-09
00745129333928Chipsleeve Arm No Hand XL Long RT SIGVARIS INCKMO2026-01-09
00745129333935Chipsleeve Arm No Hand XL Reg LT SIGVARIS INCKMO2026-01-09
00745129333942Chipsleeve Arm No Hand XL Reg RTSIGVARIS INCKMO2026-01-09
00745129333959Chipsleeve Arm No Hand XL Short LT SIGVARIS INCKMO2026-01-09
00745129333966Chipsleeve Arm No Hand XL Short RT SIGVARIS INCKMO2026-01-09
00745129333973Chipsleeve Arm No Hand XXL Long LT SIGVARIS INCKMO2026-01-09
00745129333980Chipsleeve Arm No Hand XXL Long RT SIGVARIS INCKMO2026-01-09
00745129333997Chipsleeve Arm No Hand XXL Reg LT SIGVARIS INCKMO2026-01-09
00745129334000Chipsleeve Arm No Hand XXL Reg RT SIGVARIS INCKMO2026-01-09
00745129334017Chipsleeve Arm No Hand XXL Short LT SIGVARIS INCKMO2026-01-09
00745129334024Chipsleeve Arm No Hand XXL Short RT SIGVARIS INCKMO2026-01-09