FDA.reportPublic FDA data

PeelPro®

Primary DI
D6870088000FG2
Brand
PeelPro®
Company
Sultan Healthcare Inc
Model
88000
Device description
PeelPro® Self-Sealing Sterilization Pouch 2.75 x 10 (70mm x 254mm) Box of 200
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953829000SAFE-T-SEALGs Medical Packaging, Inc.1995-11-09KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6870088000FG2PackageHIBCC6In Commercial Distribution
D687880001PrimaryHIBCC0
D687880000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width10Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-8825xx@xx.xx

Regulatory Flags#

DUNS number
056296981
Device count
200
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
true
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
D6870031103FG1Durashield® CV0031103FG2016-09-23
D6870031104FG1Durashield® CV0031104FG2016-09-23
D6870031105FG1Durashield® CV0031105FG2016-09-23
D6870031106FG1Durashield® CV0031106FG2016-09-23
D6870020361SA1Com-Fit0020361SA2017-07-18
D687215001Cleanlets21500215002022-11-30
D687215051Cleanlets21505215052022-11-30
D687215201ReSURGE™ 21520215202022-12-05
D687AD320121Topex® AD32012AD320122022-12-05
D687AD33004FG13-WayAD33000FGAD33004FG2022-12-05
D687215200ReSURGE™ 21520215202022-12-05
D687215211ReSURGE™ 21521215212022-12-05
D687AD320120Topex® AD32012AD320122022-12-05
D687AD33004FG03-WayAD33000FGAD33004FG2022-12-05
D687AD320101Topex® AD32010AD320102022-12-03
D687AD320111Topex® AD32010AD320112022-12-03
D687AD320131Topex® AD32010AD320132022-12-03
D687AD321011Topex® AD32010AD321012022-12-03
D687AD321021Topex® AD32010AD321022022-12-03
D687AD321031Topex® AD32010AD321032022-12-03

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Primary DI, Brand, Company table
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00653159014239CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014246CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014253CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014260CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014277CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
07630031779656Straumann Modular CassetteInstitut Straumann AGKCT2026-06-03
00810157315229Basic Surgical KitParagon Implant Mfg., LLCKCT2026-06-02
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
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07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
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07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344178353MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344177783MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177790MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177950MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15