Welch Allyn, Inc.

Primary DI
00732094080612
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901075
Catalog number
35323
Device description
Welch Allyn 6.0 V Halogen Fiber-Optic Sigmoidoscope Set including Three Fiber-Optic Rigid Sigmoidoscopes with Obturators (#32410 15 mm x 15 cm, #32820 19 mm x 25 cm, #37023 23 mm x 7 cm), 30 cm Suction Tube (#30130), Insufflation Bulb (#30200), Fiber-Optic Light Head (#36019), Light Handle with 3.0 ft/0.9 m Cord (#73211), Power Transformer with 5.0 ft/1.2 m Cord, Two Halogen Replacement Lamps (#07800-U), Hard Storage Case (#05391-U); 230 V, 50 Hz AC, IEC Plug Type-E/F
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DLXHEMAGGLUTINATION INHIBITION, BARBITURATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLXHemagglutination Inhibition, BarbiturateClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K770291000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K770291000SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125Welch Allyn, Inc.1977-02-18FAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094080612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094080612007320940806127320940806120732094080612

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags#

DUNS number
198227881
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00732094089479Welch Allyn, Inc.901081117202016-09-17
00817655023106Welch Allyn, Inc.9011454197342019-10-23
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094319903Welch Allyn, Inc.9010114198322023-09-26
00732094326079Welch Allyn, Inc.9010069293-024-512023-08-25
00732094247138Welch Allyn, Inc.90103139500-TE2019-08-28
00732094247145Welch Allyn, Inc.90103139500-NP-TE2019-08-28
00732094272338Welch Allyn, Inc.90115211094-001-502020-03-24
00732094258905Welch Allyn, Inc.90113411012-014-502020-03-20
00732094307351Welch Allyn, Inc.9011454197512019-10-23
00732094307368Welch Allyn, Inc.9011454133792019-10-23
00732094307375Welch Allyn, Inc.9011454197332019-10-23
00732094258998Welch Allyn, Inc.901011036840-0052019-09-26
00732094272673Welch Allyn, Inc.901011036840-0062019-09-26
00817655020679Welch Allyn, Inc.90113411012-016-502019-09-26
00817655020686Welch Allyn, Inc.90113411012-016-512019-09-26
00732094296341Welch Allyn, Inc.90101211093-003-502019-06-11
00732094223910Welch Allyn, Inc.9011084112152023-08-24