FDA.reportPublic FDA data

Unipack

Primary DI
40665973030737
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
UBC-80392
Catalog number
UBC-80392
Device description
Tube Sleeves 2" x 1200' Roll
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRDUnit, operative dental, accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40665973030737PackageGS14In Commercial Distribution
10665973030736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4066597303073740665973030737
1066597303073610665973030736

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
018319397
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10665973029839UnipackUGC-6610-LUGC-6610-L2022-12-06
10665973029846UnipackUGC-6610-MUGC-6610-M2022-12-06
10665973029853UnipackUGC-6610-SUGC-6610-S2022-12-06
10665973029860UnipackUGC-6610-XLUGC-6610-XL2022-12-06
10665973029877UnipackUGC-6610-XXLUGC-6610-XXL2022-12-06
10665973030347UnipackUGJ-6510-LUGJ-6510-L2022-12-06
10665973030354UnipackUGJ-6510-MUGJ-6510-M2022-12-06
10665973030361UnipackUGJ-6510-SUGJ-6510-S2022-12-06
10665973030378UnipackUGJ-6510-XLUGJ-6510-XL2022-12-06
10665973030385UnipackUGJ-6510-XXLUGJ-6510-XXL2022-12-06
10850008682237UnipackUMA-9121-FUMA-9121-F2022-12-07
10850008682244UnipackUMA-9122-RUMA-9122-R2022-12-07
10850008682251UnipackUMA-9123-AUMA-9123-A2022-12-07
D784UBC8010E5UnipackUBC-8010EUBC-8010E2022-12-07
D784UBC8011A5UnipackUBC-8011AUBC-8011A2022-12-07
D784UBC8012B5UnipackUBC-8012BUBC-8012B2022-12-07
D784UBC8013F5UnipackUBC-8013FUBC-8013F2022-12-07
D784UBC80235UnipackUBC-8023UBC-80232022-12-07
D784UBC80245UnipackUBC-8024UBC-80242022-12-07
D784UBC80255UnipackUBC-8025UBC-80252022-12-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D12517802Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
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00810126506511Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506528Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506535Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506559Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506573Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00817169023708Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
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