FDA.reportPublic FDA data

36PW - Nova Scotia - SBK - Poly White

Primary DI
00766588080369
Brand
36PW - Nova Scotia - SBK - Poly White
Company
Certified Safety Manufacturing, Inc.
Model
S208-036
Catalog number
S208-036
Device description
36PW - Nova Scotia - SBK - Poly White
Published
2022-05-15
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMPPAD, EYE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMPPad, EyeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766588080369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588080369007665880803697665880803690766588080369

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze rollA sterile device in the form of a long strip of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(816)483-9090Info@certifiedsafety.com

Regulatory Flags#

DUNS number
788460483
Device count
1
DM exempt
false
Premarket exempt
false
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
00766588260037Naloxone - 16 Poly ClearK626-003K626-0032026-05-26
00766588420103Forceps - MagnifierR242-010R242-0102026-05-26
10766588420100Forceps - Magnifier UDI/10R242-010R242-0102026-05-26
00766588260051Burn Dressing Small - Red Velcro BagK626-005K626-0052026-03-23
00766588127675RR - UP Vehicle - 75 RefillKR612-067KR612-0672026-03-02
00766588249810Class B 21 ANSI Plus - RTB 5186K624-981K624-9812026-03-02
0076658825009050 Person Contractors Kit - 24 Poly WhiteK625-009K625-0092026-03-02
00766588235714607 QF Strips Plastic 1"x 3" 16/BoxR523-571R523-5712026-02-05
00766588235998QF C-Protector Mouth-to-Mouth BarrierR523-599R523-5992026-02-05
00766588251035PG&E Field Class B 21 Plus - Jump Bag 5210K625-103K625-1032026-02-05
00766588252070Snake Bite EconomyR525-207R525-2072026-02-05
00766588252087PG&E Expirables - ZLBR525-208R525-2082026-02-05
00766588260013Safety General PurposeK626-001K626-0012026-02-05
00766588250076Safety General Purpose - 10 Poly WhiteK625-007K625-0072025-12-18
00766588235745628 - Non-Stick Pads 2"x 3" - 4/unitR523-574R523-5742025-12-17
00766588120676RR - UP Facilities - 75VK612-067K612-0672025-12-15
00766588235721608 - Adhesive Bandages Plastic 2"x 3" - 6/unitR523-572R523-5722025-12-15
00766588160825816 - Nitrile Gloves - 2 pr/unitR216-082R216-0822025-12-08
00766588190051QF Tape 1/2" x 2.5 yds. - RollR519-005R519-0052025-12-08
00766588250083Safety General Purpose - 16 Poly WhiteK625-008K625-0082025-12-08

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Primary DI, Brand, Company table
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08682952413262PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
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06974567748078RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2023-03-03
04042809687477Leukoplast®BSN medical GmbHHMP2022-12-08
04042809687521Leukoplast®BSN medical GmbHHMP2022-12-08
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30665973018073American White CrossDukal LLCHMP2022-12-06
06974567745299EMSRUNWuxi Emsrun Technology Co., Ltd.HMP2022-12-02
30665973018097American White CrossDukal LLCHMP2022-12-02