FDA.reportPublic FDA data

MEDLINE

Primary DI
30884389085268
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYND70420S
Catalog number
DYND70420S
Device description
SPECULUM,VAGINAL,SMALL,DISPO,NON-STER
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIBSpeculum, vaginal, nonmetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389085265PackageGS110In Commercial Distribution
30884389085268PrimaryGS10
10884389085264Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438908526540884389085265
3088438908526830884389085268
1088438908526410884389085264

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal retractor, self-retainingA self-locking, surgical instrument, used for separating the edges of the vagina and holding back the tissue allowing a surgical intervention or examination. The instrument may resemble a large pair of scissors or have an open circle design with pointed, blunted, or wire-like blades or claws that grasp and part the tissue of the vaginal opening. It is typically made of stainless steel and comes in a variety of designs. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Label does not mention Storage Conditions

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
10
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344216123MEDLINESSBCS21GLSSBCS21GL2026-07-24
10197344219575MEDLINEMDS99905MDS999052026-07-24
10653160391326MEDLINEEBSI1865EBSI18652026-07-24
30193489017742MEDLINE6651CBL22X16651CBL22X12026-07-24
30193489017759MEDLINE6651CBL22X26651CBL22X22026-07-24
30193489017766MEDLINE6651CBL22X36651CBL22X32026-07-24
30193489017773MEDLINE6651CBL22X46651CBL22X42026-07-24
30193489017780MEDLINE6651CBL34X36651CBL34X32026-07-24
30193489017797MEDLINE6651CBL34X46651CBL34X42026-07-24
30193489104893MEDLINEMDT011201XLMDT011201XL2026-07-24
40193489107969MEDLINEMDTISO3AHCAR3MDTISO3AHCAR32026-07-24
40193489120241MEDLINEMDTISO3AHGMDTISO3AHG2026-07-24
40193489120258MEDLINEMDTISO3AHG3XLMDTISO3AHG3XL2026-07-24
50080196247576MEDLINEMDT011205MDT0112052026-07-24
50193489109885MEDLINEMDTISO3AHY3XLMDTISO3AHY3XL2026-07-24
50193489109892MEDLINEMDTISO3AHYCARMDTISO3AHYCAR2026-07-24
10193489987522MEDLINEURO175814TURO175814T2022-05-22
10193489987546MEDLINEURO175818TURO175818T2022-05-22
10193489988505MEDLINEURO175816TURO175816T2022-05-22
00080196311661MEDLINENON241278NON2412782026-07-23

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