FDA.reportPublic FDA data

NA

Primary DI
04715309125250
Brand
NA
Company
PANPAC MEDICAL CORPORATION
Model
BA100
Device description
The Uterine Sound is used to gauge the depth and position of the uterine cavity. It is also helpful with the placement of IUDs and the verification of the intrauterine position and length for HSG procedures. The proximal portion of the sound is 3.5 mm in diameter tapering to 2.5 mm at the distal portion with a bulbous tip to reduce the risk of perforation. Malleable to adapt to anatomical variations.It is a sterile, disposable, single-use only device.
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHMSound, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHMSound, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04715309122037PackageGS125In Commercial Distribution
04715309125250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04715309122037047153091220374715309122037
04715309125250047153091252504715309125250

GMDN Terms#

Term, Definition table
TermDefinition
Uterine sound, single-useA sterile, hand-held manual instrument designed to measure and/or explore the internal depth or length of the uterus, cervix, and/or vagina. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+866286472242service@panpac.com.tw

Regulatory Flags#

DUNS number
657528899
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04713025224004NABA05F-S2018-07-09
04715309122891The O.R. Company LLCUMI 4.5C-D2016-08-15
04715309122914The O.R. Company LLCUMI 4.5KC-D2016-08-15
04715309124987NAM00142016-08-15
04715309124994NARD0032016-08-15
04715309125014NAM00162016-08-15
04715309125021NAM00152016-08-15
04715309125038NAWC-400MM2016-08-15
04715309125045NABA05F2016-08-15
04715309125052NABA07F2016-08-15
04715309125069NAUIC5F2016-08-15
04715309125113NABA051F2016-08-15
04715309125120NABA071F2016-08-15
04715309125137NAUI 4.02016-08-15
04715309125144NAUI 2.02016-08-15
04715309125151NAUIC5FA2016-08-15
04715309125182NAUIC5FAX2016-08-15
04715309125199NAUMI 4.52016-08-15
04715309125205NAUMI 4.5K2016-08-15
04715309125229NAUMI 4.5C2016-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776408442MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419295MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419301MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419318MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419325MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419332MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419356MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419363MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419370MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776413361MillenniumAvalign Technologies, Inc.HHM2025-10-09
00194613017545MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613085841MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613111083MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00190776405670MillenniumAvalign Technologies, Inc.HHM2025-07-18
00190776405687MillenniumAvalign Technologies, Inc.HHM2025-07-18
04049047110064GimmiGimmi GmbHHHM2025-05-27
04049047110071GimmiGimmi GmbHHHM2025-05-27
04049047110088GimmiGimmi GmbHHHM2025-05-27
04049047110095GimmiGimmi GmbHHHM2025-05-27
04049047110101GimmiGimmi GmbHHHM2025-05-27
04049047110118GimmiGimmi GmbHHHM2025-05-27
04049047110125GimmiGimmi GmbHHHM2025-05-27
04049047110132GimmiGimmi GmbHHHM2025-05-27
04049047110149GimmiGimmi GmbHHHM2025-05-27
04049047110156GimmiGimmi GmbHHHM2025-05-27
04049047110163GimmiGimmi GmbHHHM2025-05-27
04049047110170GimmiGimmi GmbHHHM2025-05-27
04049047110187GimmiGimmi GmbHHHM2025-05-27
04049047110194GimmiGimmi GmbHHHM2025-05-27
04049047110200GimmiGimmi GmbHHHM2025-05-27