FDA.reportPublic FDA data

Sureglide

Primary DI
00855009006092
Brand
Sureglide
Company
ECOMED SOLUTIONS, LLC
Model
ECO158005
Catalog number
ECO158005
Device description
Sureglide Safety Scalpel
Published
2017-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDXScalpel, One-Piece

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855009006099PackageGS110In Commercial Distribution
20855009006096PackageGS110In Commercial Distribution
00855009006092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085500900609910855009006099
2085500900609620855009006096
00855009006092008550090060928550090060920855009006092

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)817-7114onestop@ecomed-solutions.com

Regulatory Flags#

DUNS number
079814353
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855009006009Ecomed Angiographic128-200101128-2001012017-09-21
00855009006016Ecomed Angiographic128-200107D128-200107D2017-09-21
00855009006023Ecomed Angiographic128-100302128-1003022017-09-21
00855009006047Ecomed Angiographic128-T60012128-T600122017-09-21
00855009006054Ecomed Angiographic128-I90107128-I901072017-09-21
00855009006108Ecomed Angiographic128-200301128-2003012017-09-21
00855009006115Ecomed Angiographic128-200301A128-200301A2017-09-21
00855009006122Ecomed Angiographic128-100301128-1003012017-09-21
00855009006139Ecomed Angiographic128-200201128-2002012017-09-21
00855009006146Ecomed Angiographic128-100201128-1002012017-09-21
00855009006153Ecomed Angiographic128-100101128-1001012017-09-21
10855009006006Ecomed Angiographic128-200101128-2001012017-09-21
10855009006013Ecomed Angiographic128-200107D128-200107D2017-09-21
10855009006020Ecomed Angiographic128-100302128-1003022017-09-21
00855009006030Ecomed Angiographic128-I60195128-I601952017-09-21
10855009006044Ecomed Angiographic128-T60012128-T600122017-09-21
10855009006051Ecomed Angiographic128-I90107128-I901072017-09-21
10855009006105Ecomed Angiographic128-200301128-2003012017-09-21
10855009006112Ecomed Angiographic128-200301A128-200301A2017-09-21
10855009006129Ecomed Angiographic128-100301128-1003012017-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227353ScalpelTreace Medical Concepts, Inc.GDX2026-06-05
00810111227346Scalpel Treace Medical Concepts, Inc.GDX2026-05-19
00850069257002LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257019LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257026LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257040LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257057LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257064LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257071LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257088LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257095LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257101LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257118LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257033LumohsNANO SURGICAL, INCGDX2026-02-20
16945630141826STERiLANCESterilance Medical (Suzhou) Inc.GDX2026-02-05
00818788021892Epimed International, Inc.EPIMED INTERNATIONAL, INCGDX2025-11-21
16945630137584index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137591index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137607index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137614index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139069index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139076index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
10198459343490MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GDX2025-05-22
16945630114080BardSterilance Medical (Suzhou) Inc.GDX2025-02-28
10197344025190MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025206MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025213MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
08902895129212KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129229KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129236KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09