FDA.report

Dermapac, Inc.

Primary DI
00810102271129
Brand
Dermapac, Inc.
Company
Dermapac Inc.
Model
8122
Device description
Plastic Bags 8" x 4" x 18" 6/pk
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KDCInstrument, Surgical, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810102271126PrimaryGS10
00810102271129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010227112610810102271126
00810102271129008101022711298101022711290810102271129

GMDN Terms

TermDefinition
Instrument management bagA flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
203-924-7148dermapac@msn.com

Regulatory Flags

DUNS number
796088466
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
00810102270009Dermapac, Inc.18032022-09-12
00810102270016Dermapac, Inc.18042022-09-12
00810102270023Dermapac, Inc.18052022-09-12
00810102270030Dermapac, Inc.18092022-09-12
00810102270047Dermapac, Inc.18102022-09-12
00810102270054Dermapac, Inc.18122022-09-12
00810102270061Dermapac, Inc.18142022-09-12
00810102270078Dermapac, Inc.18152022-09-12
00810102270085Dermapac, Inc.18322022-09-12
00810102270092Dermapac, Inc.18602022-09-12
00810102270108Dermapac, Inc.20342022-09-12
00810102270115Dermapac, Inc.20362022-09-12
00810102270122Dermapac, Inc.20382022-09-12
00810102270139Dermapac, Inc.2080-B2022-09-12
00810102270146Dermapac, Inc.20812022-09-12
00810102270153Dermapac, Inc.20872022-09-12
00810102270160Dermapac, Inc.21392022-09-12
00810102270177Dermapac, Inc.21402022-09-12
00810102270184Dermapac, Inc.21422022-09-12
00810102270191Dermapac, Inc.50032022-09-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00887482138373SterionASPEN SURGICAL PRODUCTS, INC.KDC2026-02-15
10653160391098Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDC2025-12-19
06946480584224Disposable Skin Staple Removers Sinolinks Medical Innovation Co., Ltd.KDC2025-09-04
00194613020576MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613043209MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613044381MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613044633MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045296MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045302MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045531MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613047153MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054250MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054441MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054472MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054496MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054571MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054762MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613062163MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088026MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088101MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088118MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088132MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088194MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089672MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089757MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089764MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613090890MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613091330MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613091774MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613093228MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01