FDA.reportPublic FDA data

Dealmed

Primary DI
00817415020253
Brand
Dealmed
Company
DEALMED MEDICAL SUPPLIES LLC
Model
782412
Catalog number
782412
Device description
Vaginal Speculum Medium Disposable, 10/Bx
Published
2020-12-04
Public version status
New
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
00817415020260PackageGS110In Commercial Distribution
00817415020253PrimaryGS10
00817415020932Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817415020260008174150202608174150202600817415020260
00817415020253008174150202538174150202530817415020253
00817415020932008174150209328174150209320817415020932

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, examination, single-useA hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device.

Regulatory Flags#

DUNS number
068586441
Device count
10
DM exempt
true
Premarket exempt
true
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
00817415020086Dealmed7875307875302022-08-29
00859140003125Dealmed7875207875202022-08-29
10817415021653Dealmed7831327831322021-09-30
10817415021844DEALMED7838227838222021-09-17
00859140003750Dealmed8591400037577830432020-09-11
00859140003798Dealmed7838047838042020-12-04
00817415021861Dealmed7864017864012021-04-26
00817415021878Dealmed7864027864022021-04-26
00817415021885Dealmed7864037864032021-04-26
00817415023049Dealmed7864047864042022-07-18
00817415023087Dealmed7864087864082022-07-28
00817415023063Dealmed7864067864062022-07-28
00817415020468Dealmed7836197836192020-12-04
00817415020512Dealmed7835037835032020-12-04
00817415021069Dealmed7885257885252021-06-11
00817415022370Dealmed7832527832522022-08-29
00817415022387Dealmed7832537832532022-08-29
00817415022394Dealmed7832547832542022-08-29
00817415022400Dealmed8079458079452021-10-25
00817415021083Dealmed7830327830322020-12-04

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