FDA.reportPublic FDA data

Midway Select

Primary DI
10843717103612
Brand
Midway Select
Company
MIDWAY DENTAL SUPPLY, LLC
Model
002-0343
Device description
"Midway Select Sutures 4-0 Chromic Gut C6 18"" (12)"
Published
2020-01-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GALSuture, Absorbable, Natural

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896554000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896554000GUT SUTURESLook, Inc.1990-05-31GAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843717103612PrimaryGS10
00843717103615Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084371710361210843717103612
00843717103615008437171036158437171036150843717103615

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, plainA sterile, single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
102354446
Device count
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10843717102547Midway Select002-02572019-07-19
10843717102721Midway Select002-02582019-07-19
10843717106699Midway Select002-04952021-04-05
10843717106705Midway Select002-04962021-04-05
10843717106712Midway Select002-04972021-04-05
10843717106729Midway Select002-04982021-04-05
10843717106736Midway Select002-04992021-04-05
10843717106743Midway Select002-05002021-04-05
10843717106750Midway Select002-05012021-04-05
10843717106767Midway Select002-05022021-04-05
10843717106774Midway Select002-05032021-04-05
10843717106781Midway Select002-05042021-04-05
10843717106798Midway Select002-05052021-04-05
10843717106804Midway Select002-05062021-04-05
10843717106811Midway Select002-05092021-04-05
10843717106828Midway Select002-05102021-04-05
10843717106835Midway Select002-05112021-04-05
10843717106842Midway Select002-05122021-04-05
10843717106859Midway Select002-05132021-04-05
10843717106866Midway Select002-05142021-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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