FDA.reportPublic FDA data

Disposable Vaginal Specula, Small

Primary DI
00616784491424
Brand
Disposable Vaginal Specula, Small
Company
Dynarex Corporation
Model
4914
Device description
Graves Style, With Light Source Option, Ready to Use, Do Not Boil or Autoclave
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00616784491431PackageGS14In Commercial Distribution
00616784491424PrimaryGS10
00810180845540Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784491431006167844914316167844914310616784491431
00616784491424006167844914246167844914240616784491424
00810180845540008101808455408101808455400810180845540

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, single-useA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
25
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117320987Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc Canister324092026-09-25
00840117352735dmecare Solutions Folding Beside Commode103702021-04-22
00840117352742dmecare Solutions Elongated Folding Bedside Commode103712021-04-22
00840117308855Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL342212022-05-11
00616784431321Junior Tongue Depressors, 5 1/2" (14.0 cm)43132021-09-01
00616784431420Senior Tongue Depressors, 6" (15.2 cm)43142021-09-01
00616784435213Gait Belt, Natural Colors, Metal Buckle, 60" x 2"43522021-09-01
00616784435312Gait Belt, Multicolor, Metal Buckle, 60" x 2"43532021-09-01
00616784435411Gait Belt, Multicolor, Wipeable Plastic Buckle, 60" x 2"43542021-09-01
00616784351612Heavy Duty Fitted Cot Sheet, White, 30" x 73"35162021-09-01
00616784351711Premium Flat Cot Sheet, Dark Blue, 40" x 85"35172021-09-01
00616784368115Triangular Bandages, Non-Woven, Polybagged, 40" x 40" x 56"36812021-09-01
00616784369228Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd36922021-09-01
00616784369327Cotton Stockinette, Soft Stretch Bandage, 3" x 25 yd36932021-09-01
00616784369426Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd36942021-09-01
00616784369624Cotton Stockinette36962021-09-01
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)70552026-06-30
00616784201221Lab Jackets Knitted Cuffs & Collar with Pockets, Small, Blue20122021-09-01
00616784201320Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, Blue20132021-09-01
00616784201429Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue20142021-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199536930087BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930094BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930100BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930117BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00888937027389OfficeSPECCoopersurgical, Inc.HIB2026-08-06
00888937027396HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027402HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027419HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027426ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027433ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027440ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027457ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027464ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027327ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027334ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027341ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027358HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027365HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027372HER-SpecCoopersurgical, Inc.HIB2026-08-05
00860015815705Rosa SpeculumMY VILLAGE INNOVATIONS INC.HIB2026-07-20
20860000270421Nella Next Reusable Vaginal SpeculumCEEK WOMEN'S HEALTHHIB2026-06-25
00860000270496Nella Comfort Kit First Time ExamCEEK WOMEN'S HEALTHHIB2026-05-05
00860000270472Nella Comfort Kit Classic RetailCEEK WOMEN'S HEALTHHIB2026-04-15
00860000270489Nella Comfort Kit Curves RetailCEEK WOMEN'S HEALTHHIB2026-04-15
10860008900309ClearSpecClearspec LLCHIB2025-10-29
10860008900316ClearSpecClearspec LLCHIB2025-10-29
10860008900323ClearSpecClearspec LLCHIB2025-10-29
10860008900330ClearSpecClearspec LLCHIB2025-10-29