FDA.reportPublic FDA data

BARR-SHUFORD RECTAL SPECULUM

Primary DI
00192896044463
Brand
BARR-SHUFORD RECTAL SPECULUM
Company
SONTEC INSTRUMENTS, INC.
Model
508-328
Catalog number
508-328
Device description
BARR-SHUFORD RECTAL SPECULUM
Published
2018-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFQSPECULUM, RECTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896044463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896044463001928960444631928960444630192896044463

GMDN Terms#

Term, Definition table
TermDefinition
Rectal speculumA hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896015104REEH STITCH SCISSORS13-832513-83252018-09-12
00192896062238RYDER NEEDLE HOLDER2300-3152300-3152018-09-12
00192896105171Small Plates355-236A355-236A2020-10-05
00192896122833Intraocular Set1100-034-SET1100-034-SET2026-03-19
00192896122840Alyea-Babcock Vasectomy Clamp516-695516-6952026-03-19
00192896122857Diamond Head Grasping Forceps1273-1251273-1252026-03-19
00192896122864Velociraptor Junior Rongeur1273-171F1273-171F2026-03-19
00192896122871Spoon Curette2900-2222900-2222026-03-19
00192896122888Dissector2900-2332900-2332026-03-19
00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
00192896122949Deluxe Alligator Grasping Forceps1100-333D1100-333D2026-03-19
00192896122680Schroeder Vulsellum Bone Clamp1103-0641103-0642026-03-10
00192896122697Cooley Vascular Clamp2100-527C2100-527C2026-03-10
00192896122703Ochsner Dissector2700-155T2700-155T2026-03-10
00192896122710Debakey Coarctation Clamp2100-6312100-6312026-03-10
00192896122727Debakey Coarctation Clamp2100-6352100-6352026-03-10

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Primary DI, Brand, Company table
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00198506084201ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-07-17
00190776402983MillenniumAvalign Technologies, Inc.FFQ2025-06-30
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00190776399634MillenniumAvalign Technologies, Inc.FFQ2025-06-02
00190776399764MillenniumAvalign Technologies, Inc.FFQ2025-06-02
04049047074663GimmiGimmi GmbHFFQ2025-05-20
04049047074670GimmiGimmi GmbHFFQ2025-05-20
04049047316848GimmiGimmi GmbHFFQ2025-05-20
00190776393717MillenniumAvalign Technologies, Inc.FFQ2025-05-06
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00190776393748MillenniumAvalign Technologies, Inc.FFQ2025-05-06
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00198506082610ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-05-06
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00198506082375ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-04-21
00198506081248ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-03-14
00198506075537ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-02-21
00198506074066ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-01-03
00198506073816ELMED INCORPORATEDELMED INCORPORATEDFFQ2024-12-19
00190776389918MillenniumAvalign Technologies, Inc.FFQ2024-11-18
00190776389130MillenniumAvalign Technologies, Inc.FFQ2024-11-14
00198506073243ELMED INCORPORATEDELMED INCORPORATEDFFQ2024-11-11