FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403060922
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
SU210
Catalog number
SU210
Device description
CHELSEA EATON ANAL SPECULUM SMALL DIAMETER 7/8" (2.2CM) OVERALL LENGTH 2-1/2" (6.4CM)
Published
2018-09-17
Public version status
Update
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
10885403060922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540306092210885403060922

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
832696038
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
50382909101206Surgiphor9101209101202026-03-05
10885403273780PleurX50-007550-00752017-06-12
10885403075964PleurX50-905050-90502017-06-12
50885403075993Denver42-200042-20002017-06-12
50885403076006Denver42-205542-20552017-06-12
50885403076082Denver42-205042-20502017-06-12
10885403051722V. MuellerHY21305HY213052017-08-11
10885403049408V. MuellerGU4050-008GU4050-0082018-08-30
10885403071263V. MuellerNL1350NL13502018-09-05
10885403105159V. MuellerOS5000-002OS5000-0022018-09-10
20885403473170N/A5513E5513E2019-03-25
50885403142176Wet Exidine448944892018-07-18
50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506087691ELMED INCORPORATEDELMED INCORPORATEDFFQ2026-01-16
00198506085376ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-09-09
00198506085017ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-09-05
00190776409180MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776409265MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776409272MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776408299MillenniumAvalign Technologies, Inc.FFQ2025-08-07
00198506084201ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-07-17
00190776402983MillenniumAvalign Technologies, Inc.FFQ2025-06-30
00190776399627MillenniumAvalign Technologies, Inc.FFQ2025-06-02
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
00190776393724MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393731MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393748MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393755MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00198506082610ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-05-06
00190776393182MillenniumAvalign Technologies, Inc.FFQ2025-05-05
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