FDA.reportPublic FDA data

Susol® Ulcer Debridement Pack USA (Pack of 10)

Primary DI
05060418835996
Brand
Susol® Ulcer Debridement Pack USA (Pack of 10)
Company
BAILEY INSTRUMENTS LTD
Model
SSP-132
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MCYWound Dressing Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCYWound Dressing KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060418835996PackageGS110In Commercial Distribution
05060418836191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060418835996050604188359965060418835996
05060418836191050604188361915060418836191

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, non-medicatedA collection of instruments and dressings intended to be used to dress a wound. Items typically include scissors, forceps, gauze, and cotton-tip applicators; it does not contain a pharmaceutical. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
769260357
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
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
05060418834661Susol® Henckel Tilley Punch Forceps 4.5mmSS42-32152024-05-14
05060418833343Susol® Henckel Tilley Punch Forceps 4.5mmSS42-32152024-05-14
05060418833695Susol® Diamond Bur Pear 2S-DB182024-02-27
05060418833725Susol® Diamond Bur Pear 1S-DB42024-02-27
05060418833732Susol® Diamond Bur 15CS-DB72024-02-27
05060418833749Susol® Diamond Bur 1HP EnucleatorS-DB82024-02-27
05060418833992Susol® Blacks File SE Standard 14cmSS08-05522024-02-27
05060418834012Susol® Probe Flat Head Swan Neck 12.5cmSS08-05562024-02-27
05060418834029Susol® Blacks File Double Ended Micro with Round Probe 14cmSS08-05572024-02-27
05060418833671Susol® Emery Board 18cmCH1452024-02-27
05060418832377Susol® Diamond Bur Pear 2S-DB182024-02-27
05060418832407Susol® Diamond Bur Pear 1S-DB42024-02-27
05060418832414Susol® Diamond Bur 15CS-DB72024-02-27
05060418832421Susol® Diamond Bur 1HP EnucleatorS-DB82024-02-27
05060418832674Susol® Blacks File SE Standard 14cmSS08-05522024-02-27
05060418832698Susol® Probe Flat Head Swan Neck 12.5cmSS08-05562024-02-27
05060418832704Susol® Blacks File Double Ended Micro with Round Probe 14cmSS08-05572024-02-27
05060418836177Susol® Micro Curette Double Ended with holeSS62-43002024-02-27
05060418834883 Susol® Nail Care SetBSDP-022024-02-20
05060418833640 Susol® Nail Care SetBSDP-022024-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459428623MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10198459433474MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10198459171789Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-11-24
10653160381518MEDLINEMEDLINE INDUSTRIES, INC.MCY2024-10-28
10198459057939Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-10-20
10195327657833Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
10195327667924Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
10198459053849Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-06-30
10195327559182Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-12-21
10193489360479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10193489417005Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10193489417043Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10195327421298Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10195327297725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-13
10193489398335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489398427Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489399820Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489399929Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489411560Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489416954Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418286Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418385Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418392Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418408Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489420982Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489421088Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489421606Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489423600Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489432121Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489432138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08