FDA.reportPublic FDA data

OKTAPE

Primary DI
06979191881962
Brand
OKTAPE
Company
HTT Technologies, Inc.
Model
4003-A1
Published
2026-07-31
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

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16979191881969PackageGS120In Commercial Distribution
06979191881962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697919188196916979191881969
06979191881962069791918819626979191881962

GMDN Terms#

Term, Definition table
TermDefinition
Surgical dressing/drape kit, single-useA collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device.

Regulatory Flags#

DUNS number
119508078
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979191883744OKTAPE6211-BW2026-09-02
06979191883751OKTAPE6229-LBU22026-09-02
06979191883768OKTAPE6211-RD2026-09-02
06979191883775OKTAPE6211-GN2026-09-02
06979191883591OKTAPE4004-A22026-07-31
06979191881955OKTAPE4003-A02026-07-31
06979191881979OKTAPE4003-A22026-07-31
06979191883607OKTAPE4004-A32026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260223630224curea P1curea medical GmbHNAC2026-09-27
04260223630231curea P1curea medical GmbHNAC2026-09-27
04260223630248curea P1curea medical GmbHNAC2026-09-27
04260223630255curea P1curea medical GmbHNAC2026-09-27
04260223630262curea P1curea medical GmbHNAC2026-09-27
04260223630279curea P1curea medical GmbHNAC2026-09-27
04260223630286curea P1 draincurea medical GmbHNAC2026-09-27
04260223630347curea P2curea medical GmbHNAC2026-09-27
04260223630378curea P2curea medical GmbHNAC2026-09-27
04260223630408curea P2curea medical GmbHNAC2026-09-27
04260223630422curea P2curea medical GmbHNAC2026-09-27
04260223630651curea P1curea medical GmbHNAC2026-09-27
04260223630668curea P2curea medical GmbHNAC2026-09-27
04260223630736curea P1curea medical GmbHNAC2026-09-27
04260223630880curea P1curea medical GmbHNAC2026-09-27
04260223630989curea P1 heelcurea medical GmbHNAC2026-09-27
04260223631184curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631191curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631207curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631214curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631368curea P1curea medical GmbHNAC2026-09-27
04260223631672curea P2curea medical GmbHNAC2026-09-27
04260223631696curea P2curea medical GmbHNAC2026-09-27
04260223631757curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631771curea P2 activecurea medical GmbHNAC2026-09-27
04260223631795curea P2 activecurea medical GmbHNAC2026-09-27
04260223631849curea P2 activecurea medical GmbHNAC2026-09-27
04260223631931curea P1 easy bordercurea medical GmbHNAC2026-09-27
00749756401920DeRoyalDEROYAL INDUSTRIES, INC.NAC2026-09-18
00841277111286Novera SeamHarps USA, Inc.NAC2026-09-04