NA

Primary DI
04715309122174
Brand
NA
Company
PANPAC MEDICAL CORPORATION
Model
DT-B/L
Device description
"""Panpac Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus.Panpac Vaginal Dilators has four different size (small, medium, large and extra large) in three family types; Family A, Family B and Family C with variant sizes."""
Published
2016-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDXDilator, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDXDilator, VaginalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130273000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130273000PANPAC VAGINAL DILATORSPanpac Medical Corporation2013-08-08HDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04715309122174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04715309122174047153091221744715309122174

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal dilatorA firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
657528899
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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

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00810142352215Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352222Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352239Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352246Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352260Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352277Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352284Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352291Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352314Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-12
00810142352253Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-08
00850005838029Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838036Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838043Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838050Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838067Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838074Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838081Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838098Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838104Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838111Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838128Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00860012225002Hope&Her Vaginal DilatorsLUJENA, INC.HDX2024-11-15
B8034701660ORTHOMEDORTHO-MED, INC.HDX2024-05-17
04719894432236BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432243BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432250BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432267BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432274BiotequeBioteque Taiwan Ltd.HDX2024-04-08